Preparation of an effective informed consent document presents significant problems to those investigators not familiar with federal and institutional requirements. This article examines a detailed format for preparation of an informed consent instrument. Prepared by the authors and supplied to potential clinical investigators by a university institutional review committee, the guidelines incorporate Department of Health, Education, and Welfare regulations. An example consent form is provided.
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References
1.
21 Code of Federal Regulations § 310.102 (h).
2.
U.S. Department of Health, Education, and Welfare. Report to the Congress; federal control of new drug testing is not adequately protecting human subjects and the public. Food and Drug Administration, July 15, 1976.
